Regulatory Affairs for Medical devices

We provide flexible, tailored solutions through both consultancy services and embedded in-house support, adapting seamlessly to your organisation’s operational, quality, and regulatory requirements

Our consulting and support services for the Medical Device Industry

Regulatory Strategy

We provide strategic regulatory advice to support your product development pathway. This includes device classification, as well as the development of a clear regulatory strategy outlining key submission requirements and a defined approach to achieving CE or UKCA marking.

Expert Panel Advice, Orphan Device Designation, Breakthrough Device Designation

We have significant experience in managing regulatory authority procedures, including engagement with EMA expert panels.

We can provide comprehensive support and submission expertise for Orphan Device Designation and Breakthrough Device Designation applications in the EU.

Clinical Investigations

We provide end-to-end support for clinical investigations in the UK and EU, including preparation, submission, and maintenance through to study completion.

We also author clinical investigation documentation, ensuring full alignment with current regulatory requirements.

Quality Management System (QMS)

We can help you implement a compliant QMS in line with ISO 13485, EU MDR 2017/745, UK MDR 2002 (as amended) and ISO 9001, to help you establish comprehensive procedures in accordance with current regulations and standards. We can also carry out gap analysis of existing systems that require transitioning to new requirements. Additionally, we can provide personnel to integrate within the day to day QMS oversight activities.

Auditing (Internal, Suppliers, Regulatory Bodies)

Our experienced and qualified auditors can meet all your QMS auditing requirements. We can perform audits in line with ISO 13485, EU MDR 2017/745, UK MDR 2002 (as amended) and ISO 9001. We can also help you prepare for Notified Body or Approved Body QMS audits.

Quality Agreements

As part of supplier management requirements you may require quality agreements to be drawn up. We have the expertise to help with quality agreements and establishing elements to meet various requirements.

Promotional Material Review

There are strict rules and codes of practise to be adhered to for the advertising of medicinal products. Non-promotional information such as press releases can also be considered as disguised advertising. Therefore careful review and scrutiny of any outgoing pieces is critical. S-cubed has experience and can assist with the review of materials for both prescription and non-prescription products.

GDPR Consulting

We can advise companies on the requirements of the GDPR for clinical trial activity in the EU. For further information please contact us.

Technical Documentation Review and Gap Analysis

We perform technical documentation reviews and gap analyses, providing clear recommendations to address gaps in-line with current legislation and applicable guidelines.

CE and UKCA Marking

We have extensive experience managing regulatory submissions through to approval, including interactions with notified bodies and approved bodies.

We provide expert guidance across the full scope of medical device lifecycle management and post-market activities.

Regulatory Intelligence

We can prepare reports on the latest developments in medical device regulation, helping you stay up-to-date with evolving requirements and supporting your business needs.

We develop Regulatory Intelligence position papers to address specific regulatory or product development questions, or to summarise key topics and highlight relevant considerations.

We also deliver presentations across a wide range of regulatory topics to support knowledge sharing and capability building within your organisation.

Regulatory Affairs

We can provide you with a wide range of regulatory affairs support for EU and UK:

Device classification
Technical File development
Clinical investigations document preparations and submissions
Notified Body and Approved Body interactions
Drug/device combination product expertise
Regulatory strategies for approval
Expertise in CE or UKCA marking submissions

Post Market and Medical Device Lifecycle Management

We can provide you with advice to guide you through the requirements of medical device lifecycle management and post market activities. We can support you with activities such as ongoing post market surveillance, periodic safety reviews, device classification specific post market commitments and clinical evaluations.

EU Legal Representative

We can be your local EU representatives. The Authorized Representative is the door to Europe (EEA, Switzerland and Turkey) and a regulatory requirement.

DPO Services

As a requirement of the GDPR legislation in Europe, the large scale collection of health related data requires the appointment of a Data Protection Officer (DPO). S-cubed has experience of acting as a DPO. We can coordinate all necessary tasks related to this role and ensure general compliance with the GDPR